Senior Director, Regulatory Affairs
Improving quality-of-life through innovations in urology.
Urovant Sciences (Nasdaq: UROV) is a clinical-stage biopharmaceutical company focused on developing and commercializing innovative therapies for urologic conditions. Urovant is a company with an entrepreneurial focus on improving the way providers and their patients confront urologic diseases that are difficult to treat.
Every employee at Urovant plays an integral role to our success. We are ambitious in our approach to improving outcomes for the patients and healthcare providers we serve. Our fast-paced environment rewards strategic decision-making and collaboration, giving team members opportunities to grow beyond their expertise.
Urovant’s lead product candidate, vibegron, an oral, once-daily small molecule beta-3 agonist is being developed for overactive bladder (OAB). In addition to OAB, vibegron is being evaluated for two additional potential indications: the treatment of OAB in men with benign prostatic hyperplasia (BPH) and the treatment of abdominal pain associated with irritable bowel syndrome (IBS).
Urovant’s second investigational product candidate, URO-902, is a novel gene therapy for patients with overactive bladder symptoms who have failed oral pharmacologic therapy.
The Senior Director of Regulatory Affairs, within Urovant’s Regulatory Affairs and Quality organization, is responsible for development and implementation of regulatory affairs strategy as a member of multi-disciplinary pharmaceutical product development teams.
- Represent the regulatory affairs function on assigned cross-functional small molecule and biologic pharmaceutical product development teams.
- Develop and implement global regulatory affairs strategy in accordance with applicable regulations/guidelines (e.g. US FDA, EMA, ICH, etc.) (for clinical trials and registration) for supported programs.
- Plan, prepare, author, and/or review submissions (e.g. IND, CTA, BLA, NDA, MAA) to health authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products.
- May serve as primary liaison with FDA (and other health authorities, as appropriate) for day-to-day interactions.
- Coordinate and prepare responses to requests for information from health authorities.
- Prepare meeting requests, briefing documents, coordinate and prepare teams for meetings with health authorities.
- Monitor, analyze, and disseminate intelligence on regulatory matters that may affect ongoing development programs.
- Participate in due diligence evaluations of potential in-license/partnering opportunities.
The Senior Director, Regulatory Affairs should be able to travel, including international travel, for at least 30% of time, depending on business needs.
Education and Experience
- Bachelor’s degree required, with an advanced scientific degree (PhD, PharmD, MD) strongly preferred
- At least 6 years’ experience in Regulatory Affairs
Essential Skills and Abilities
- Regulatory Affairs experience in therapeutic areas of company focus; urology, gastroenterology, and oncology
- Regulatory Affairs experience with multiple therapeutic modalities; small molecules, biologics, gene therapies, drug/device combination products, and therapeutic devices
- Ability to work effectively in a cross-functional team environment
- Exceptional organizational skills with the ability to manage multiple complex projects/tasks at the same time, and to effectively prioritize deliverables
- Excellent written and oral communication skills
- Highly proficient using Microsoft Word, Excel, PowerPoint, Project, and SharePoint; or similar applications and systems.
- Strong financial business acumen and analytical skills; ability to develop and manage expenditures in accordance with budget
- A commitment to collaborative leadership, management, teamwork, delegation and the maintenance of a professional culture based on trust and mutual respect